News

Dr Vinay Prasad's FDA exit in less than 3 months linked to Sarepta gene therapy controversy? Check details
Dr. Vinay Prasad, a controversial figure and critic of the FDA, resigned from his high-ranking position at the agency after ...
Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy
Dr. Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...
The New York Sun5h
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Dr. Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on ...
Just The News7h
FDA allows distribution of muscular dystrophy drug again after public criticism
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
BioSpace8h
Prasad Out at CBER Following Sarepta Rollercoaster and Conservative Criticism
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...
BioWorld12h
Apellis’ Empaveli approved in US for two rare kidney diseases
The approval to reduce proteinuria for those 12 and older with either of the two severe and rare kidney diseases came on the July 28 PDUFA date, a little more than four years after the company won ...
Sarepta soars after FDA says some patients can get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
Sarepta Therapeutics, Inc. (SRPT): “You Don’t Court Homicide,” Says Jim Cramer
We recently published 11 Stocks That Jim Cramer Recently Talked About. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the ...
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...
Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
Shares of Sarepta surged Tuesday, a day after the FDA said the company could lift a voluntary pause on shipments of its Elevidys drug, which had been linked to three patient deaths this year. The ...